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NCT06801535NARecruiting

Efficacy of 3D-Printed Mouth Splints

Wake Forest University Health Sciences

Start Date

2/21/2025

Completion Date

12/1/2026

Summary

The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient progress in functionality and quality of life.

Detailed Description

Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).

Eligibility Criteria

Age Range: 2 years to 99 years

Inclusion Criteria: * Patients 2 years to 99 years of age with documented microstomia following burn injuries. * Ability to comply with prescribed home exercises and follow-up visits. Exclusion Criteria: * Cognitive or physical inability to perform the prescribed exercises. * Inability of a caretaker to be able to deliver therapy daily. * Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).

Interventions

DEVICE

Splint

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Conditions

Microstomia

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States